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Obstetric and Neonatal Outcomes of Twin Pregnancy

Obstetric and Neonatal Outcomes of Twin Pregnancy (Twin Conception-To-Birth): A Multicenter International Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04588597
Acronym
Twin-CTB
Enrollment
300
Registered
2020-10-19
Start date
2020-11-01
Completion date
2022-03-01
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin Pregnancy

Keywords

Twin pregnancy, maternal outcomes, neonatal outcomes, machine learning

Brief summary

This multicenter study aims at assessing the natural history of twin pregnancy and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes. This study will include at least 12 centers from different countries that present at least Europe, South America, Asia, and Africa. Data will be retrospectively collected from January 1st, 2010 to December 31st, 2019.

Detailed description

Twin pregnancies carry higher risks of maternal, fetal and neonatal adverse outcomes compared to singleton pregnancy.They are associated with increased perinatal morbidity and mortality, anemia, pregnancy- induced hypertension, increased incidence of cesarean section (CS), postpartum hemorrhage, prematurity and low birth weight and Increased rate of perinatal death. This multicenter study aims at assessing the natural history of twin pregnancy, and developing a machine learning-based algorithm to predict clinical outcomes of twin pregnancy during pregnancy and delivery and to determine management strategies that are associated with best maternal and neonatal outcomes. Medical records of eligible women will be reviewed, and data abstraction will be performed using a standardized excel sheet designed for this study. Target data include baseline demographics and clinical data (e.g. age, parity, ethnicity, smoking, IVF pregnancy, history of gynecologic surgeries, type of twin pregnancy, current medical disorders, current obstetric complications, fetal anomalies, administration of antenatal steroids, Placental site, and twin-specific complications). Information from serial ultrasound reports including fetal growth and Doppler studies will be collected and data on fetal intervention will be abstracted. Peripartum data include node of delivery, Method of induction, CS indication, and type of cesarean incision. Clinical outcomes include postpartum hemorrhage, and perinatal death, admission to neonatal intensive care unit (NICU), neonatal need for respiratory support, neonatal intracranial hemorrhage, neonatal respiratory distress syndrome and neonatal hypoxic ischemic encephalopathy. Data will not include any identifiable information. Prediction model will be created using baseline demographic and obstetric features of pregnancy and individual maternal and perinatal complications will be set as outcomes (dependent variables). A composite outcome of major maternal and neonatal outcomes will be created separately.

Interventions

None listed

Sponsors

Middle-East OBGYN Graduate Education Foundation
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. Women with twin pregnancy who received their antenatal care and were delivered in the participating institute 2. Compliance to antenatal care visits

Exclusion criteria

1. Major fetal anomalies of one or both twins 2. Elective miscarriage 3. Authorization to use medical records was not provided by the patient

Design outcomes

Primary

MeasureTime frameDescription
Postpartum hemorrhageFrom delivery of the baby to 24 hours postoperative (Total of 24 hours)Significant uterine bleeding \> 1000 ml
perinatal deathFrom onset of labor to 1 week postnatalDeath of the baby during delivery or early neonatal period
Admission to neonatal intensive care unit (NICU)From delivery of the baby to 24 hours postoperative (Total of 24 hours)Admission of the baby to NICU for observation or intervention
Intrauterine fetal deathDeath of the fetus any time from 24 weeks to onset of labor

Contacts

Primary ContactSherif A Shazly, M.Sc
sherif.shazly.mogge@gmail.com+15075131392
Backup ContactMohamed A Salah
mohamed.ashraf.mogge@gmail.com0201223987685

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026